Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

European Commission Oks Novartis' Afinitor Tablets For Treatment Of HR+/HER2

7/30/2012 1:33 AM ET

Novartis International AG (NVS: Quote) said the European Commission has approved Afinitor (everolimus) tablets for treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival, or PFS, to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.

Besides, an additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months. The most common grade 3-4 adverse reactions were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.

Click here to receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Justin Moore has been named Humanitarian of the Year by by the Armed Forces Foundation. Moore received the award alongside Big Machine Label Group President/CEO Scott Borchetta for their service and commitment to the morale and welfare of military families through the Crown Royal "Your Hero's Name Here" contest. International Business Machines Corp. said Wednesday after the markets closed that its first quarter profit fell 21% from last year, hurt by lower revenue as well as a hefty workforce rebalancing charge. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Stocks moved sharply higher over the course of the trading day on Wednesday, further offsetting the steep losses posted late last week. The markets benefited from a positive reaction to the latest earnings news as well as remarks by Federal Reserve Chairman Janet Yellen. The major averages saw further upside going into the close, ending the session at their best levels of the day.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.